The following data is part of a premarket notification filed by Gyneco, Inc. with the FDA for Syncare Temporary Cardiac Pacing Wire.
| Device ID | K861409 |
| 510k Number | K861409 |
| Device Name: | SYNCARE TEMPORARY CARDIAC PACING WIRE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | GYNECO, INC. 51 CHUBB WAY Branchburg, NJ 08876 |
| Contact | Buday, Ph.d. |
| Correspondent | Buday, Ph.d. GYNECO, INC. 51 CHUBB WAY Branchburg, NJ 08876 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-15 |
| Decision Date | 1986-05-05 |